EP0898944B1 - Prosthetic device for the repair of a hernia - Google Patents

Prosthetic device for the repair of a hernia Download PDF

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Publication number
EP0898944B1
EP0898944B1 EP98306855A EP98306855A EP0898944B1 EP 0898944 B1 EP0898944 B1 EP 0898944B1 EP 98306855 A EP98306855 A EP 98306855A EP 98306855 A EP98306855 A EP 98306855A EP 0898944 B1 EP0898944 B1 EP 0898944B1
Authority
EP
European Patent Office
Prior art keywords
canal
hernia
base
collar
hernial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP98306855A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0898944A2 (en
EP0898944A3 (en
Inventor
Vishvaroop Agarwal
Carlos Bustamante
Gene W. Kammerer
Donald G. Hill
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Inc
Original Assignee
Ethicon Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Inc filed Critical Ethicon Inc
Publication of EP0898944A2 publication Critical patent/EP0898944A2/en
Publication of EP0898944A3 publication Critical patent/EP0898944A3/en
Application granted granted Critical
Publication of EP0898944B1 publication Critical patent/EP0898944B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern

Definitions

  • hernial canal repair is generally carried out by suturing.
  • that method of repair is not entirely satisfactory: given that the suture line is subject to a large amount of tension, there is a risk of tearing, which could then lead to recurrence of the hernia.
  • a known technique is to position a sheet of synthetic prosthesis material, of knit or woven mesh, over the hernial canal, to reinforce or replace the weakened tissue.
  • a sheet or patch of mesh may be used which is positioned on the inguinal ring, on the side remote from the peritoneum, this sheet being slit to allow the spermatic cord to pass, and the two tails of the patch are then wound around the spermatic cord.
  • the barrier thus created makes it possible for the inguinal canal floor to regenerate.
  • Such a barrier-forming sheet may also be positioned by non-invasive surgery.
  • a device using a trocar to deploy prosthesis sheets inside the abdominal cavity, on the peritoneum, is described in EP 0 544 485, for example.
  • tension-free repair technique which may be used in combination with the above-mentioned technique, consists in obturating the hernial canal with a prosthesis device.
  • prosthesis device Other shapes are also used, such as rectangular devices, conical devices or collared devices, enabling them to be positioned relative to the hernial canal.
  • the following may be consulted in that respect: "Prostheses in Abdominal Wall Hernia", Robert Bendavid, RG Austin, pages 375-379, 380-382, 383-388, 389-398, 408-410, 411-412, 413-414, 446-449, and also U.S. Pat. Nos. 5,116,357 and 5,356,432.
  • WO 92/19162 describes a surgical implantation device according to the preamble of claim 1 which is delivered to a hernial rupture site laproscopically.
  • WO 93/13712 describes a septal closure device comprising a deformable frame.
  • the object of the invention is to propose a prosthesis device which is simple in structure and simple to manipulate and which is also very effective.
  • the invention therefore, provides a prosthesis device to repair a hernia, the device comprising a hernia canal insert having a proximal end and distal end; the proximal end being attached to a collar and the distal end being attached to and covered by a base, characterised in that the canal insert has a passage between the proximal end and the distal end having a geometric cross-section of sufficient size to allow insertion of a finger or instrument for positioning of the device into a hernia canal.
  • a prosthesis device to repair a hernia defect comprising a canal insert for extending through said hernial canal, having a proximal end and a distal end; the proximal end being attached to a collar and the distal end of the canal insert being attached and covered by a pouch.
  • the canal insert which is inserted in the hernia defect for obturation, is reinforced by a barrier-forming part which may either constitute a sheet or a pouch which provides very good resistance to intra-abdominal pressure because it is inserted on the inside of the hernial cavity and not on the outside.
  • Figure 1 is a prospective view of the first embodiment of the hernia prosthesis of the invention (1).
  • Figure 2 is an illustration showing the top view of the first embodiment of the invention (1).
  • Figure 3 is a perspective view showing the canal insert (2) place within a hernial canal with the base (9) shown in phantom implaced intra-abdominally.
  • Figure 4 is a cross-sectional view illustrating a first possible embodiment of the invention (1).
  • Figure 5 is a cross-sectional view illustrating the placement of the first possible embodiment of the invention (1) implanted in the abdominal wall(517).
  • Figure 6 is a prospective view of the second possible embodiment of the invention (101) having a canal (104).
  • Figure 7 is a top view of the second possible embodiment of invention (101) .
  • Figure 8 is a perspective view of the second possible embodiment of the invention(101) illustrating the canal insert(102) placed within a hernial canal, with the sheet(109) shown in phantom implaced intra-abdominally.
  • Figure 9 is a cross-section view illustrating the second possible embodiment of the invention(101).
  • Figure 10 is a cross-sectional view illustrating the placement of the second possible embodiment of the invention in the abdominal wall(117).
  • Figure 11 is a perspective view of yet another embodiment of the present invention in which the collar (7) and/or canal insert (2) is not centered on the base (9).
  • FIG. 1 A perspective of one embodiment of the invention is shown in Figure 1.
  • the first embodiment of the invention 1 illustrated in Figure 1 and shown in cross-section in Figure 4 comprises three main parts: a cannular part or insert 2, which has a proximal end 3 and a distal end 5.
  • the proximal end 3 is attached to the second part, a collar 7.
  • the distal end 5 is attached to the third part, base 9, which is to be inserted inside the abdominal cavity to constitute a barrier at the internal canal of the hernial canal.
  • the hernia canal insert 2 between the proximal end and the distal end 5 has a passage 4 having a geometric cross-section of sufficient size to allow the insertion of a finger or instrument (particularly preferred are passages that are cylindrical in shape).
  • the passage 4 is shown in Figures 1, 4 and 5.
  • the canal insert 2 is attached to a collar 7 at its proximal end 3 to be positioned on the outside of the hernial cavity.
  • the collar 7 constitutes a base to facilitate fixation of the device which may be by suturing of the device by the surgeon.
  • the collar may also be constituted by a disk-shaped sheet fixed on the end of the canal insert 2.
  • the collar 7 and the base 9 may be of a shape other than circularly symmetrical.
  • the collar 7 may extend in one or more directions as one or more segments, thereby facilitating suturing in those directions.
  • the collar 7 may also be notched (i.e. with a key-hole 11, semi-circular notch 13, or other notch shape) to facilitate the passage of the spermatic cord when the device is used in indirect hernia procedures as is illustrated in Figure 3.
  • the distal end 5 of canal insert 2 to be positioned on the inside of the cavity, is attached to and extended by the base 9 which may be a single sheet of material.
  • the base 109 may be composed of a double sheet (as is illustrated in cross-section in Figures 6-10).
  • the two layers 111 and 113 are folded over one another to form a substantially flat pouch 115, of circular or elliptical periphery, for example.
  • the second embodiment of the invention as shown in cross-section in Figure 9 comprises a canal insert 102 having a first end 103 and second ends 105.
  • the first end 103 is attached to a collar 107 and the base 109 is attached to the proximal end of the canal insert 102.
  • the base 109 comprises at least two sheets respectively 111 and 113.
  • the sheets are attached and form a pouch 115.
  • the passage 104 is designed to allow a finger or surgical instrument to be inserted into the pouch 115.
  • the device-forming parts 1, 2 and the sheet(s) of part 3 are made of one or more biocompatable sheet materials.
  • the material(s) from which these parts are made is/are selected so as to be inert and infection-resistant, and so as to be quickly incorporated into tissue.
  • the device-forming parts 1, 2 and the sheet(s) of part 3 may be made of the same or different synthetic or natural material.
  • the material(s) from which these parts are made is selected so as to be inert and infection-resistant, and to be biocompatable with tissue. Numerous biocompatable absorbable and nonabsorbable materials can be used for parts 1, 2 and 3.
  • Suitable nonabsorbable materials for use in parts 1, 2 and 3 include, but are not limited to, cotton, linen, silk, polyamides (polyhexamethylene adipamide (nylon 66), polyhexamethylene sebacamide (nylon 610), polycapramide (nylon 6), polydodecanamide (nylon 12) and polyhexamethylene isophthalamide (nylon 61) copolymers and blends thereof), polyesters (e.g. polyethylene terephthalate, polybutyl terphthalate, copolymers and blends thereof), fluoropolymers (e.g. polytetrafluoroethylene) and polyolefins (e.g.
  • polypropylene including isotactic and syndiotactic polypropylene and blends thereof, as well as, blends composed predominately of isotactic or syndiotactic polypropylene blended with heterotactic polypropylene and polyethylene).
  • Suitable absorbable materials for use in parts 1, 2 and 3 include, but are not limited to, homopolymers and copolymers of glycolide, lactide (which includes L-, D-, and meso- forms of lactide and mixtures thereof), ⁇ -caprolactone, p-dioxanone, trimethylene carbonate, 1,4-dioxepan-2-one, poly(alkylene oxalate), and mixtures of such polymers with each other and with other compatible absorbable compositions as those described; for example, in US 3,636,952 and US 2,683, 136.
  • the sheets that comprise parts 1, 2 and 3 may be constructed in a variety of ways and may be films, felts, knits, wovens, crochets, braided materials or combinations thereof. Numerous surgical meshes, nets or films have been described in the literature and reference may be made to the following patents: US 2,761,444; US 3,054,406; US 3,124,136; US 4,347,847; US 4,633,873; US 4,769,038; US 5,092,884; US 5,292,328; US 5,569,273; PCT/GB95/01786 and EP 0 698 395 A1.
  • suitable sheet materials include but are not limited to, polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene or polypropylene mesh (such as ProleneTM Surgical Mesh from Johnson & Johnson), etc.
  • the sheets will preferably be surgical mesh material.
  • Surgical mesh materials are commonly knitted monofilaments, but may also be multifilaments. Additionally, the size of the filaments used to manufacture surgical meshes may vary depending on the .structure and desired properties of the knitted material.
  • the canal insert 2 may be approximately 1.27 cm high and 1.9 cm in diameter; if the collar 7 is oval the major axis may be approximately 10 cm and the minor axis 4.5 cm; if the base is circular, its diameter is for example 7.5 cm; knitted from 0.15 mm (6 mil) polypropylene monofilament.
  • the surgeon In order to insert the prosthesis device in hernial canal 519, in the abdominal wall 517, the surgeon, having dissected the peritoneal sac 521 and pushing it back into the cavity, then bunches base 9 into a tubular shape and introduces the base 9 into the hernial cavity by pushing the base through the hernia canal 519 using a finger inserted into passage 4. The surgeon will then push the base 9 into the peritoneal cavity. The surgeon's finger will temporarily push the canal insert 2 into the interior of the peritoneal cavity to create additional space to allow the base 9 to fully deploy against the inside wall of the abdomen 523.
  • the second embodiment of the invention 101 shown in Figure 10 is inserted into the hernial canal 119, the surgeon, having dissected the peritoneal sac 121 and pushing it back into the cavity, then introduces the base 109 into the outside of the abdominal cavity, while inserting the canal insert in such a way that it extends through the hernial canal 119, the collar 107 being brought to bear on the outside of the abdominal wall 117.
  • the surgeon then introduces the end of a surgical instrument (i.e. a cannula) or his finger into the pouch 115 through the passage 104 and deploys the patch so that the two sheets 111 and 113 are properly superposed and inserted, under the effect of intra-abdominal pressure, against the inside face of the abdominal cavity 123.
  • a surgical instrument i.e. a cannula
  • the surgeon may suture the collar 107 to the abdominal wall 117.
  • the barrier-forming part 3 because it is positioned inside the hernial cavity and not externally, provides excellent resistance to intra-abdominal pressure.
  • the surgeon may also introduce fiber or foam material through the passage 104, to fill the pouch 115 and the passage 104 so as to constitute a ball of fiber or foam in the pouch to absorb abdominal pressure elastically while spreading the force exerted at the hernial canal over a portion of the wall of the hernial cavity surrounding said canal.
  • the prosthetic device of the present invention may be manufactured by any appropriate technique known in the art.
  • the mesh may be cut into the appropriate shape by a cutting blade, hot knife, or ultrasonic cutting device (the last two cutting devices may provide more uniform edges).
  • the three dimensional structure of the device can be formed by shaping a sheet of mesh over a heated tool and cooling the sheet material to set the shape.
  • the mesh may be thermoformed over a heated tool in the range of from about 80°C (175° F) to about 160°C (320° F) and preferably about 118°C (245° F) under suitable pressure for a suitable amount of time (at least 10 seconds and preferably less than 30 minutes).
  • thermoforming should be conducted in a manner that does not distort or weaken the mesh structure.
  • polypropylene mesh should be compressed between a male and female forming tool which are closed together at a speed in the range of from about 2 to about 25 cm per minute and preferable at a speed of in the range of from about 5 to about 7.5 cm per minute.
  • Polypropylene meshes should generally be heated for in the range of from about 2 to about 5 minutes and cooled to below room temperature to set the shape. Currently it is preferred to cool polypropylene mesh to 13°C (55° F) or less for in the range of from about 2 to about 5 minutes.
  • the shaped sheet may then be attached to the base by an appropriate attachment means (i.e. sewing, gluing or welding).
  • One appropriate method for attaching two sheets polypropylene mesh is to ultrasonically weld the two pieces together. It is advisable with some materials (i.e. polypropylene mesh) to support the three dimensional shape in its package to insure the device maintains its shape.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
EP98306855A 1997-08-27 1998-08-26 Prosthetic device for the repair of a hernia Expired - Lifetime EP0898944B1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US5709397P 1997-08-27 1997-08-27
US57093P 1997-08-27
US09/136,036 US6241768B1 (en) 1997-08-27 1998-08-19 Prosthetic device for the repair of a hernia
US136036P 1998-08-19

Publications (3)

Publication Number Publication Date
EP0898944A2 EP0898944A2 (en) 1999-03-03
EP0898944A3 EP0898944A3 (en) 1999-08-04
EP0898944B1 true EP0898944B1 (en) 2004-05-26

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Family Applications (1)

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EP98306855A Expired - Lifetime EP0898944B1 (en) 1997-08-27 1998-08-26 Prosthetic device for the repair of a hernia

Country Status (4)

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US (1) US6241768B1 (ja)
EP (1) EP0898944B1 (ja)
JP (1) JP4531148B2 (ja)
DE (1) DE69824092T2 (ja)

Cited By (12)

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CN101098664B (zh) * 2004-10-21 2010-05-26 伊西康有限公司 外科植入物
US7828854B2 (en) 2006-10-31 2010-11-09 Ethicon, Inc. Implantable repair device
US8623034B2 (en) 2007-10-19 2014-01-07 Ethicon, Gmbh Soft tissue repair implant
US8734473B2 (en) 2009-02-18 2014-05-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US8814887B2 (en) 2005-03-01 2014-08-26 Ethicon, Inc. Surgical implant
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US9242026B2 (en) 2008-06-27 2016-01-26 Sofradim Production Biosynthetic implant for soft tissue repair
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9308068B2 (en) 2007-12-03 2016-04-12 Sofradim Production Implant for parastomal hernia
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device

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US7892246B2 (en) 1999-07-28 2011-02-22 Bioconnect Systems, Inc. Devices and methods for interconnecting conduits and closing openings in tissue
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US6592625B2 (en) 1999-10-20 2003-07-15 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and spinal disc annulus stent
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US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9242026B2 (en) 2008-06-27 2016-01-26 Sofradim Production Biosynthetic implant for soft tissue repair
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JP4531148B2 (ja) 2010-08-25
DE69824092D1 (de) 2004-07-01
US6241768B1 (en) 2001-06-05
EP0898944A2 (en) 1999-03-03
EP0898944A3 (en) 1999-08-04
DE69824092T2 (de) 2005-06-02
JPH11146888A (ja) 1999-06-02

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